Sunitinib Malate in Treating Patients With Kidney Cancer

Centre Antoine Lacassagne

Status: Completed

Conditions: Kidney Cancer

Treatments: Other: pharmacological study; Drug: sunitinib malate; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00943839

EUDRACT-2008-004137-21

2008/20

CDR0000638415

CALACASS-SUVEGIL-8

INCA-RECF0943

Details and patient eligibility

About

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.

Full description

OBJECTIVES:

Primary

• To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer.

Secondary

• To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients.
• To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment.
• To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Metastatic disease requiring first-line treatment with sunitinib malate

  • No prior therapy for metastatic disease

• No symptomatic or uncontrolled cerebral metastasis

PATIENT CHARACTERISTICS:

• Affiliation to the French Social insurance
• Life expectancy ≥ 3 months
• No heart failure
• No chronic unstable disease
• No long QT interval
• No history of another primary cancer
• No severe, uncontrolled acute infection
• No severe, uncontrolled hypertension
• No psychological disorder

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

SUVEGIL

Experimental group

Treatment:

Other: pharmacological study

Other: laboratory biomarker analysis

Drug: sunitinib malate